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Phone:  +61 2 9906 2984 
Fax:       
+61 2 8580 4613

Skype:  Skype Me™!

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Regulatory Submissions

Medical device and diagnostic regulations are undergoing rapid changes in many countries, especially across Asia Pacific and Latin America. It is essential that manufacturers and distributors have immediate access to the knowledge and skills needed to meet the latest requirements, enabling fastest access to your markets.

Brandwood Biomedical is your ideal partner for two reasons. First, we have extensive experience in bringing products to market in the ‘traditional’ regulated markets of North America, Europe and Australia. Second, with offices in Sydney, Melbourne, Hong Kong and Beijing, Brandwood Biomedical has the resources and networks across Asia Pacific, providing you with regulatory access to the fastest growing economies in the world.

We provide advice and service delivery in:

  • Initial strategic assessments of regulatory options and pathways
  • Preparation of Technical Files
  • Technical support for design and development including
    • Risk assessments
    • Product and materials testing
    • Biocompatibility
    • Sterility validation
    • Software validation
    • Electrical safety

 

 

 

 

  • Regulatory submissions for all jurisdictions including
    • China SFDA
    • Europe CE
    • US FDA
    • Australian TGA
    • Health Canada
    • Japan PMDA
    • Korean FDA
    • Taiwan FDA
    • Latin America